Often healthcare providers need clarification so as to establish a complex relationship among individuals and entities and do not understand what is and what is not permitted due to various complex laws such as the Anti-kickback law. Often salesmen will come around and seek to sell you on a particular device or testing program and try to convince you that you may bill under a particular coding when you may not be permitted at all. One avenue is to obtain a written legal opinion from an experienced Healthcare Attorney. That might be sufficient. Yet, sometimes the issues as so complex and without a clear answer due to complex enforcement policy reasons that the Healthcare Attorney will suggest that you file for an Office of Inspector General (OIG) advisory opinion.
An Office of Inspector General advisory opinion is a written legal opinion issued by OIG to one or more requesting parties about the application of the OIG’s powers to the party’s business arrangement. An OIG advisory opinion is legally binding on the Department of Health & Human Services and the requesting party or parties. It is not binding on any other office of the governmental. A party that receives a favorable advisory opinion is protected from OIG administrative sanctions, so long as the arrangement at issue is conducted in accordance with the facts submitted to the OIG. However, no person can assert an advisory opinion defense requested by someone else. Your Healthcare Attorney can advise you as to such issues. That is one of the functions that the Attorneys at the Law Office of Kenneth Joel Haber perform for their clients.
Does a Healthcare entity have to get an advisory opinion?
No, the advisory opinion process is voluntary. Failure to seek an advisory opinion about a transaction or business arrangement may not be introduced into evidence to prove that the party intended to violate the law. However, if you have an advisory opinion, it can save you from agency enforcement actions in the first place.
One might ask what are appropriate subject matters for an advisory opinion request?
Many opinions seek direction as to the application of the anti-kickback statute or its “safe harbor” provisions. While a good Healthcare Attorney may advise you as to many of the issues involved as to the statutes listed below; OIG is authorized to issue binding advisory opinions as to the application of the following laws and regulations:
• Anti-kickback Statute: Section 1128B(b) of the Social Security Act (SSA)
• Anti-kickback Safe Harbor Regulations: 42 CFR § 1001.952
• Exclusion Authorities: Section 1128 of the SSA
• Civil Monetary Penalty Authorities: Section 1128A of the SSA
• Criminal Penalties: Section 1128B of the SSA
A good Healthcare Attorney can help a party seeking an advisory opinion and can help process the request more quickly. If you need further information as to a legal opinion from an experienced Healthcare Attorney or an Advisory Opinion from the OIG, please feel free to contact the Law Office of Kenneth Joel Haber, PC at 301-670-0016 for a no obligation initial consultation.